Functional Service Provision (FSP)

CROs may differ in the style of FSP provide. At Anatomise Biostats FSP refers to a specialised outsourcing model where the client (sponsor or SME) retains direct control and management of the experts and projects involved. We provide access to skilled professionals, such as biostatisticians, bioinformaticians, data scientists, and other data-related experts, on a contractual basis, while the client maintains oversight and decision-making authority.

Key characteristics of FSP for medtech and biopharma SMEs include:

  1. Specialised Expertise: our FSP allows SMEs to access specialised expertise in critical areas like biostatistics, bioinformatics, statistical programming, and data science on a full-time contractual basis. This expertise is crucial for successful R&D and clinical trial execution and yet can be impractical to manage on a permanent basis.
  2. Flexible Resource Allocation: With FSP SMEs have the flexibility to scale their project teams up or down based on project needs and timelines. Contractors can assist with an evolving array of tasks, rather than requiring advanced negotiation of deliverables. This adaptability is especially beneficial in the dynamic and evolving landscape of clinical research.
  3. Direct Project Control: Unlike traditional outsourcing models (service subscription), where we the consulting firm manage the entire project, in FSP, the SME maintains direct control over project management, timelines, and decision-making. This allows for more fluid customisation and alignment with the SME’s specific goals. A downside of this is that it places a the burden of project direction and task-related knowledge on the SME (sponsor).
  4. Cost Management: FSP helps SMEs manage costs effectively. You only pay for the services and expertise you need for a pre-specified time period. This avoids the overhead costs and HR compliance associated with maintaining a larger in-house team.
  5. Risk Mitigation: SMEs can reduce risks associated with project delays, data quality issues, and regulatory non-compliance by leveraging outsourced expertise by FSP. At Anatomise Biostats, our contractors are experienced in industry best practices and can competently deliver results.
  6. Efficiency: By accessing specialised experts through FSP, SMEs can streamline their R&D and clinical trial processes. This efficiency allows for quicker decision-making, and potentially eliminates the wait for data and analysis results as these are retained in-house.
  7. Customization: FSP arrangements can be customised to fit the unique needs of each SME and project. SMEs can choose the level of support required for each function and adapt it on a 6 monthly basis as the project evolves.
  8. Scalability: FSP is suitable for both small-scale projects and larger, more complex initiatives. SMEs can maintain flexibility in resource allocation to match the project’s demands.
  9. Direct Relationship Building: Working directly with experts through FSP fosters a closer and more collaborative relationship between the SME and the professionals involved. This collaboration can lead to better communication and project outcomes.

Our FSP for medtech and biopharma SMEs in R&D and clinical trials is a strategic outsourcing model that empowers SMEs to access specialised data-related expertise while maintaining direct control and oversight of their projects. It offers flexibility, cost-effectiveness, and risk mitigation, making it a valuable approach for organisations with significant clinical project management experience.

Are you a smaller company?

Do you want a more holistic collaboration on study design and data related services?

Do you have less capacity for complex project management?

A service subscription may be your preferred option.